News
The field of drug analysis is an interesting and ever-changing one. There are constantly new impurities to be tested for, new regulations and new limits that must be observed in drug production. We keep an eye on the market for you and inform you about current developments here.
The Conscio Group is expanding its range of services in Austria by acquiring Reference Analytics GmbH.
Reference Analytics is a GMP-certified laboratory in Eisenstadt with focus on drug analysis, whose highly qualified team has built up experience in analytical method development, transfer and validation. By merging with the Conscio Group, Reference Analytics is now ushering in the next phase of growth together with a strong partner in order to offer its customers a broad portfolio of high-quality services for generics, biosimilars and biologics together with other companies in the group.
“We are very proud to be able to add Reference Analytics to the Conscio Group. Our goal is to support pharmaceutical companies in the areas of quality assurance and innovation through high-quality scientific services and customer orientation. The expertise of the Reference Analytics team is impressive and the portfolio perfectly complements our range of services both geographically and technically,” explains Stephan Holl, CEO of the Conscio Group.
“Over the last few years, together with our owners, we have built Reference Analytics into a strong partner for the Austrian pharmaceutical industry. We are now very pleased to be taking the next step in our development with Conscio and offering our customers an even more comprehensive service,” comments DI Alexander Doppelreiter, CEO Reference Analytics.
The Conscio Group, headquartered in Munich, is a European laboratory services provider with a network of 6 international companies in Austria, Germany, the Czech Republic and the Slovak Republic with a total of over 500 employees. The Conscio companies specialize in offering high-quality analysis and consulting services, particularly for the pharmaceutical and food industries. Since 2021, Conscio has been represented in Austria by LVA, the largest private scientific service provider for the Austrian food industry. At the main location in Klosterneuburg, over 130 highly specialized employees are available to provide expert support to a wide range of customer groups. Behind the Conscio Group is BBA Capital Partners, a long-term family holding company based in Munich.
Conscio Holding GmbH: info@consciogroup.com
Reference Analytics GmbH; Thomas-Alva-Edison-Straße 1 · 7000 Eisenstadt
In 2022 and 2023 contamination with high levels of Diethylene Glycol (DEG) and Ethylene Glycol (EG) in oral liquid drug products were reported by numerous countries. These drugs included
- cough,
- allergy,
- analygesic and
- antiemetic drug products,
and led to more than 300 fatalities, mostly in children under the age of 5.
Therefore, a series of warning letters was released by the FDA on August 3rd, 2023. According to the FDA, companies have failed to conduct identity testing to verify each component of their drug product. However, identity testing is mandatory according to 21 CFR 211.84(d)(1).
Drug safety is our responsibility, especially when children’s lives are at risk.
Reference Analytics is your reliable partner in identity testing! Together we can ensure drug safety for all consumers.
Sept. 2023
Summer is slowly passing, but analytical challenges remain!
The analysis of residual solvents can be tricky – so we’ve broken it down to 3 questions that drug manufacturers should ask themselves to ensure drug safety.
- What residual solvents were used in the production process?
- Are there residual solvents that interfere with each other during analysis?
- Can these solvent residues be determined in the same analytical procedure?
Our experts at Reference Analytics will be happy to help you answer these questions and work with you to find the right solution for your individual challenge. Contact us!
August 2023